Patellar Component for Lubinus Patellar
FDA 510(k) K800800 · Waldemar Link GmbH & Co. KG
510(k) numberK800800
Submission
- Device name
- Patellar Component for Lubinus Patellar
- Applicant
- Waldemar Link GmbH & Co. KG
Mchenry, IL, US - Received
- April 10, 1980
- Decision date
- April 21, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTG – Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3580
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HTG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K771708 | Worrell PatellaHTG · Traditional | Depuy, Inc. | 10/06/1977SE |
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Questions and answers
When was Patellar Component for Lubinus Patellar cleared by the FDA?
Patellar Component for Lubinus Patellar (K800800) received a 510(k) decision of Substantially Equivalent on April 21, 1980, 11 days after the submission was received.
What is the product code of K800800?
The FDA product code is HTG – Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3580.